CHLORTHALIDONE

Product NDC: 59746-760
11-digit product format: 597460760
Labeler code: 59746
Product ID: 59746-760_51e6a425-96fd-4941-8c4d-4ba8c5dfb762
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Chlorthalidone
Dosage form: TABLET
Route: ORAL
Labeler: JUBILANT CADISTA PHARMACEUTICALS,INC.
Application: ANDA211320
Marketing category: ANDA
Marketing start: 2021-03-31
Substance: CHLORTHALIDONE
Active strength: 25 mg/1
Pharmacologic classes: Increased Diuresis [PE], Thiazide-like Diuretic [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A211320-001	CHLORTHALIDONE	CHLORTHALIDONE	25MG	TABLET / ORAL	AB		2022-02-09
A211320-002	CHLORTHALIDONE	CHLORTHALIDONE	50MG	TABLET / ORAL	AB		2022-02-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A211320-001	AB
A211320-002	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 64 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A211320-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2022-02-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211320-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2022-02-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211320-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2022-02-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211320-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2022-02-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211320-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2022-02-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211320-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2022-02-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211320-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2022-02-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211320-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2022-02-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211320-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2022-02-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211320-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2022-02-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211320-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2022-02-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211320-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2022-02-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211320-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2022-02-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211320-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2022-02-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211320-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2022-02-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211320-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2022-02-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211320-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2022-02-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211320-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2022-02-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211320-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2022-02-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211320-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2022-02-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211320-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2022-02-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211320-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2022-02-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211320-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2022-02-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211320-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2022-02-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211320-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2022-02-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211320-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2022-02-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211320-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2022-02-09	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211320-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2022-02-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211320-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2022-02-09	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211320-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2022-02-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211320-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2022-02-09	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211320-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2022-02-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211320-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2022-02-09	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211320-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2022-02-09	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211320-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2022-02-09	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211320-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2022-02-09	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211320-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2022-02-09	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211320-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2022-02-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211320-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2022-02-09	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A211320-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2022-02-09	`1c564ffb4f44…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 64 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A211320-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211320-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211320-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211320-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211320-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211320-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211320-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211320-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211320-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211320-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211320-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211320-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211320-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211320-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211320-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211320-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211320-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211320-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211320-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211320-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211320-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211320-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211320-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211320-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211320-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211320-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211320-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211320-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211320-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211320-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211320-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211320-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211320-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211320-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211320-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211320-002	AB	1	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211320-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211320-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211320-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A211320-002	AB	1	`1c564ffb4f44…`

Additional Listing Data#

Finished product: Yes
Brand name base: CHLORTHALIDONE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CHLORTHALIDONE	25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
Q0MQD1073Q	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197499	Internal RxNorm lookup
197500	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
ca0df4ae-c424-44d2-8611-1637f1a101a8	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
83fe98fe-2a14-448c-9029-41f7600d1b0a	Product name	1	20260105
0450926f-f624-49c2-83be-42807e8fbcd5	Product name	1	20251113
8525e779-537f-e5cc-2515-089ecce5f50f	Product name	9	20221128
faf41ef3-b4b3-a29e-3b26-07c3009003bf	Product name	5	20220517
3f5e2da3-8b99-f714-3261-2c998ee07b05	Product name	1	20140508
7667d8e2-e5be-36e1-4de7-231aa7fdaf5c	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
59746-760-01	CHLORTHALIDONE	100 in 1 BOTTLE	TABLET	100		2
59746-760-36	CHLORTHALIDONE	1000 in 1 BOTTLE	TABLET	1000		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59746-760-01	EA - Each	59746-760	b351567d-af92-4e42-9eda-07a0e321ad15	1	2022-11-07
59746-760-36	EA - Each	59746-760	aa30630d-63ef-481a-b750-a0347bb3c1b2	1	2022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59746-760	CHLORTHALIDONE TABLET [JUBILANT CADISTA PHARMACEUTICALS,INC.]	2	Current NDC, Legacy NDC, 2 package rows	20221202_ca0df4ae-c424-44d2-8611-1637f1a101a8.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CHLORTHALIDONE	CHLORTHALIDONE	Preferred Pharmaceuticals Inc.	da0fe4da-a4f3-4aa8-84f4-4d31c5cbdb0e	2026-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211320 application number: ANDA211320
CHLORTHALIDONE	CHLORTHALIDONE	Bryant Ranch Prepack	f46fd743-3661-41b7-b12d-30d96692f0ee	2026-04-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211320 application number: ANDA211320
CHLORTHALIDONE	CHLORTHALIDONE	REMEDYREPACK INC.	50936b5f-3eb8-4ff8-96b3-0aa4a8f77a98	2026-03-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211320 application number: ANDA211320
CHLORTHALIDONE	CHLORTHALIDONE	Rising Pharma Holdings, Inc.	71b1d074-0521-4cd1-beb5-fedd61f52eca	2024-11-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211320 application number: ANDA211320
CHLORTHALIDONE	CHLORTHALIDONE	Bryant Ranch Prepack	1ba595d4-b105-4d52-90dd-0fb8bda1fe1b	2023-11-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211320 application number: ANDA211320
CHLORTHALIDONE	CHLORTHALIDONE	JUBILANT CADISTA PHARMACEUTICALS,INC.	ca0df4ae-c424-44d2-8611-1637f1a101a8	2022-11-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211320 application number: ANDA211320 ndc (product): 59746-760

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
Q0MQD1073Q	CHLORTHALIDONE	77-36-1	CHLORTHALIDONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197499	chlorthalidone 25 MG Oral Tablet	PSN	1ba595d4-b105-4d52-90dd-0fb8bda1fe1b	100
197499	chlorthalidone 25 MG Oral Tablet	SCD	1ba595d4-b105-4d52-90dd-0fb8bda1fe1b	100
197499	chlorthalidone 25 MG Oral Tablet	PSN	ca0df4ae-c424-44d2-8611-1637f1a101a8	2
197500	chlorthalidone 50 MG Oral Tablet	PSN	ca0df4ae-c424-44d2-8611-1637f1a101a8	2
197499	chlorthalidone 25 MG Oral Tablet	SCD	ca0df4ae-c424-44d2-8611-1637f1a101a8	2
197500	chlorthalidone 50 MG Oral Tablet	SCD	ca0df4ae-c424-44d2-8611-1637f1a101a8	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59746-760-01	59746076001	100 TABLET in 1 BOTTLE (59746-760-01)	100 tablet	2021-03-31	0000-00-00	No	No	Current
59746-760-36	59746076036	1000 TABLET in 1 BOTTLE (59746-760-36)	1000 tablet	2021-03-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Chlorthalidone Tablets, USP	REMEDYREPACK INC.	2024-05-15	HUMAN PRESCRIPTION DRUG LABEL	1
Chlorthalidone Tablets, USP	Bryant Ranch Prepack	2023-11-30	HUMAN PRESCRIPTION DRUG LABEL	100
Chlorthalidone Tablets, USP	JUBILANT CADISTA PHARMACEUTICALS,INC. \| Inventia Healthcare Limited	2022-11-03	HUMAN PRESCRIPTION DRUG LABEL	2